A Study to Determine the Activity of Caelyx With Trastuzumab and Docetaxel in the Treatment of Metastatic Breast Cancer (Study P03679)

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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

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Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

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Reporting Groups

Description

Caelyx, Docetaxel, Trastuzumab

Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.

Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Caelyx, Docetaxel, Trastuzumab

Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.

Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.

Baseline Measures

Caelyx, Docetaxel, Trastuzumab

Overall Participants Analyzed [Units: Participants]

27

Age, Customized [Units: Years]

27

Sex: Female, Male [Units: Participants]Count of Participants

Female

27 100.0%

Male

0 0.0%

Region of Enrollment [Units: Participants]

Italy

27

Outcome Measures

1. Primary:

Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria [ Time Frame: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment. ]